This invention relates to a suture package which permits dispensing of the suture from a self-contained paperboard sleeve containing a paper card or from the paper card itself after the card is removed from the sleeve. This invention also relates to a process for inserting the suture into the paper card.
A suture is a strand of material, with or without an attached needle or needles, using for suturing, ligating or other surgical procedures.
The packaging of many commercial products is essential to the proper end use of the product and thus forms an integral part of the overall product design. The significance of packaging is most evident in the packaging of surgical sutures. It is essential that the package protect the product and maintain sterility throughout its period of potential use. Sutures may be stored in hospitals for several years, although the usual storage time is much shorter. It is essential that the package provide rapid and positive means of identification and release the product undamaged ready for use by the surgeon. There are many sizes of sutures, and many materials of construction such as catgut or polyglycolic acid for absorbables, silk, cotton, nylon, dacron, polyethylene, polypropylene, stainless steel, insulated stainless steel and other materials for use as non-absorbables. There are several different needle types in common use including pointed straight, pointed curved, three cornered straight, three cornered curved, curved both regular and reverse cutting, and needles with side cutting edges of various types. The variations and combinations of each of these to meet the preference of many surgeons for different operative procedures means that the suture manufacturer needs to supply different suture combinations running into the thousands. The importance of positive identification and efficient, economical packaging can thus be readily appreciated.
It is also important to provide convenience to the user and limit the risk of accidently enclosing foreign items in the patient by limiting the number of extraneous packaging materials associated with use of the product in the operating theater. A count is often kept to ensure that each item is accounted for and removed from the operating field. Considering the ramifications of enclosing such material in the patient accidently during surgical procedures, it is obviously essential to minimize this hazard.
It is essential that a suture package containing a surgical needle or needles, protect the suture from contact with the sharp point or cutting edge of the needle which could partially cut the suture or the package. Also, the armed needle edges and point need to be protected so as to maintain their sharpness. Finally, in a package for a multiple of sutures, it is desirable to allow for dispensing of one or more sutures at a time without becoming snarled.
In specific types of surgery, for example, cardiovascular surgery, relatively long sutures are required. Also a lot of sutures of the same needle, size, and material are generally required. Finally, double-armed sutures, i.e., sutures with a needle attached to both ends, as well as single-armed sutures are commonly used in cardio-vascular surgery.
These requirements are so rigorous and of such importance that many different package designs have been tried. For example, see U.S. Pat. Nos. 3,985,277; 3,779,375; 2,692,676 and 2,617,523. These patents are incorporated herein by reference. Generally, these patents disclose a surgical suture or sutures packaged in a plastic or foil strippable outer envelope. Contained in the strippable envelope is a one piece inner envelope. The suture strands are placed lengthwise to the inner envelope. The suture is normally prepared for the surgeon by stripping the outer envelope and transferring the inner envelope by forceps or by projecting into the sterile operating field. The one piece inner envelope is opened at the time of use.
The suture package of the present invention has advantages over these prior art patents. The sutures are contained on a paper card. The card is contained in a sterile paperboard sleeve. The paper card can then be removed from the sleeve with the sutures contained on the card. This has the advantage of allowing positive visual identification of the suture being used. This is important in cardio-vascular surgery where different sizes and types of sutures may be used. Also, the paperboard sleeve is discarded prior to entry into the surgical area. This reduces the amount of material in the operating area. Finally, because the card is removed from the sleeve, the card can be laid flat under a towel on a surgical tray which can then be stacked with instruments for use.
Alternatively, the sleeve containing the card can be laid flat under a towel on a surgical tray. The inside of the needle protection flap of the sleeve can then be labelled allowing positive visual identification of the suture being used.
Another advantage is that more than one card may then be removed and used in tandem. This should facilitate faster and easier dispensing of the sutures.
Another advantage is that because the sutures are contained on the card by holes there is less fraying when the package is transported and during dispensing. This feature is especially important in bioabsorbable sutures, e.g., polyglycolic acid, where the suture is manufactured to dissolve in a certain period of time
Still, another advantage is that the dispensibility of the card is not lost when the card is folded. That is, when the suture is placed on the card by use of the holes, the card can then be folded accordion style. The card containing the sutures can then be extended at the point of use and the sutures dispensed from under a sterile towel. Thus, the paper sleeve containing the card can be varied in length. This could be utilized as an identification means for sutures of various sizes or thicknesses.
The suture retention slits are oriented within the card and paperboard sleeve to allow immediate use when grasped by the needle holder or by hand. This is a desired operating room and surgical procedure technique, as it reduces the amount of time between extracting the suture from the label to its actual use as a suture. Still further, in most operations and surgical procedures, the materials used for the operation or surgical procedure are counted subsequent to the operation or surgical procedure. The card or cards of the present invention provide a readily identifiable and countable material. Finally, the size of the needle and the type of suture strand can be printed on the card. This provides ready identification in a surgical procedure where more than one size and type of suture is used. The possibility of a mix-up in the sizes and types is also reduced because the suture is dispensed from the card.